FDA Approves Subcutaneous Administration of VELCADE® In All Approved Indications

Study met primary efficacy endpoint of non-inferiority between subcutaneous and intravenous administration.Study results also indicated overall similar safety profile with differences in incidence of peripheral neuropathy.

01.23.12

The approval is based on results from a randomized, phase 3 trial conducted with 222 bortezomib-naïve relapsed patients in 53 centers in 10 countries across Asia, Europe, and South America. Patients receiving VELCADE subcutaneously achieved an overall response rate similar to that of those receiving VELCADE intravenously. The important difference is that the rate of peripheral neuropathy was substantially lower in the subcutaneous arm of the trial.

What that means for those of us in the myeloma community is that physicians treating patients including those with poor vein access or who have peripheral neuropathy and those at high risk of developing it now have another weapon in their armamentarium against myeloma.